[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"knee-arthroplasty\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:knee-arthroplasty":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,52,80,103,126,150,176,207,231,248],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100609293","development-of-an-outcome-score-for-patients-with-knee-osteoarthritis-and-knee-joint-endoprosthesis-using-an-app-100609293",false,"NCT07212699","Development of an Outcome Score for Patients With Knee Osteoarthritis and Knee Joint Endoprosthesis Using an App","Pilot Study: Development of an Outcome Score for Patients With Knee Osteoarthritis and\u002For Knee Joint Endoprosthesis Using an App Developed at the Clinic for Orthopedics","KneeApp","Inclusion criteria:\n\n* aged 18 years or older\n* german speaking\n* signed informed consent\n* using own smartphone\n\nExclusion criteria:\n\n* age below 18 years.\n* Lack of informed consent\n* no smartphone\n* non-German-speaking",true,"ALL","18 Years",{"count":21,"type":22},1250,"ESTIMATED","INTERVENTIONAL",[25],"NA","Total knee arthroplasty (TKA) and total hip arthroplasty (THA) is one of the most frequent orthopedic procedures. Over 50% of patients report higher expectations than their surgeons, and 10-50% remain dissatisfied postoperatively. Persistent pain, functional limitations, and unmet expectations are key drivers. Identifying risks pre- and early postoperatively is essential, alongside empowering patients through self-management.\n\nExisting scoring systems integrate PROMs, demographics, and sometimes imaging but within limited timeframes. They rarely capture functional deficits or long-term trajectories. Digital health solutions for TKA (pre-)rehabilitation exist, yet most focus on physiotherapy and education rather than predictive outcome modeling.\n\nTo address this gap, the study team has developed a novel mobile application that enables the documentation and analysis of movement data up to 10 years before surgery and throughout long-term follow-up. These data are combined with PROMs and functional test results, providing a unique basis for outcome prediction and risk stratification in TKA\u002FTHA.\n\nPrimary Objective The aim of this pilot study is to develop a composite outcome score for TKA\u002FTHA patients. This score will integrate demographic variables, PROMs, and objective functional measures (knee joint angles, gait parameters, walk tests) to identify risk factors for dissatisfaction and support predictive modeling. A machine learning algorithm will be trained using the collected dataset to predict patient satisfaction after TKA\u002FTHA.\n\nEndpoints Primary endpoint: Overall patient satisfaction Secondary endpoints: Age, height, weight, step count, step length, gait asymmetry, gait speed, double support phase, knee joint ROM, walk test, KOOS, SF-36, EQ5d, satisfaction with the app, and satisfaction with app use.\n\nStudy Population App-Group: Inclusion criteria are patients ≥18 years before or after TKA\u002FTHA. Exclusion criteria include missing consent, ineligible diagnosis, lack of smartphone, age \\\u003C18 years, or insufficient German language skills (as no English version of the app is currently available). Planned enrollment: 450 patients.\n\nNon-App-Group: Inclusion criteria are patients ≥18 years before or after TKA\u002FTHA. Exclusion criteria include missing consent, ineligible diagnosis, age \\\u003C18 years, or insufficient German language skills (as no English version of the app is currently available). Planned enrollment: 450 patients.\n\nHealthy-group: Inclusion criteria are healthy proband ≥18 years with no lower limb conditions. The overall procedure is identical to that of the AppGroup. Exclusion criteria include missing consent, ineligible diagnosis, no smartphone, age \\\u003C18 years, or insufficient German language skills (as no English version of the app is currently available). Planned enrollment: 450 patients.\n\nMethods Design: Single-center, prospective pilot study. The app collects patient-authorized movement data already stored on smartphones as well as future data. Participants choose which data to share. In addition, they are prompted to complete gait tests and knee function tests. PROMs (KOOS, SF-36, satisfaction) are administered at regular intervals.",[28,29,30,31],"Knee Osteoarthritis","Knee Arthroplasty","Hip Osteoarthritis","Hip Arthroplasty",[33,34,35,36,37,38],"knee","app","arthroplasty","detection","risk score","hip","RECRUITING","2026-03-31",{"date":42,"type":43},"2026-04-06","ACTUAL",{"date":45,"type":43},"2025-10-01",{"date":47,"type":22},"2028-08-31",{"name":49,"class":50},"Technical University of Munich","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100612001","the-impact-of-patient-education-delivered-through-virtual-reality-100612001","NCT07247903","The Impact of Patient Education Delivered Through Virtual Reality","The Effect of Virtual Reality-Based Education on Preoperative Surgical Fear, Postoperative Pain and Patient Satisfaction in Patients Undergoing Knee Arthroplasty: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Be 18 years of age or older,\n* Agree to participate in volunteer work,\n* Have no communication problems in terms of vision, hearing, and perception,\n* Be able to read, speak, and understand Turkish,\n* Have no fear of enclosed spaces.\n\nExclusion Criteria:\n\n* Bilateral Total Knee Arthroplasty.\n* Admission to the clinic on the day of surgery.",{"count":60,"type":22},70,[25],"Objective: A randomized controlled trial was designed to determine the effect of virtual reality-based education provided to patients undergoing knee arthroplasty on preoperative surgical fear, postoperative pain, and patient satisfaction.\n\nMaterials and Methods: The study was designed as a randomized controlled experimental study, with the group receiving animation-based patient education via virtual reality goggles serving as the experimental group and the group receiving routine patient education at the clinic serving as the control group. Research data will be collected using a patient characteristics form prepared by the researcher based on a literature review, a surgical fear scale, a visual analog scale, and a patient education satisfaction scale. Virtual reality glasses will be used as the application tool in the study.",[29],[65,66,67,68,69],"virtual reality","pain","surgical fear","patient satisfaction","knee arthroplasty","NOT_YET_RECRUITING","2026-01-21",{"date":73,"type":43},"2026-01-22",{"date":75,"type":22},"2026-01-12",{"date":77,"type":22},"2026-09-01",{"name":79,"class":50},"Ankara Yildirim Beyazıt University",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":51},"100619973","knee-arthroplasty-recovery-with-transcranial-direct-current-stimulation-100619973","NCT07351578","Knee Arthroplasty Recovery With Transcranial Direct Current Stimulation","Knee Arthroplasty Recovery With Transcranial Direct Current Stimulation: A Randomized Controlled Pilot Trial","KART","Inclusion Criteria:\n\n1. 18 years of age or older.\n2. American Society of Anesthesiologists (ASA) Physical Classification Status I-III.\n3. Scheduled to undergo unilateral elective primary total knee arthroplasty for advanced osteoarthritis of the knee.\n4. Access to a device running iOS Version 10.0 or above, or Android Version 5.0 or above that can connect to the internet.\n\nExclusion Criteria:\n\n1. History of brain surgery, central nervous system tumors, seizures (including epilepsy), stroke or intracranial implants (e.g plates, screws, deep brain stimulators)\n2. Have vascular, traumatic, infectious, or metabolic lesions or diseases of the brain\n3. Active diagnosis of a sleep disorder, defined as a documented diagnosis of any of the following conditions within the past 12 months, based on patient history or medical record review:\n\n   * Insomnia disorder (e.g., difficulty initiating or maintaining sleep, early morning awakening)\n   * Obstructive sleep apnea (OSA)\n   * Central sleep apnea\n   * Narcolepsy\n   * Restless legs syndrome\n   * REM sleep behavior disorder\n   * Circadian rhythm sleep-wake disorders\n   * Parasomnias (e.g., sleepwalking, night terrors)\n4. Active diagnosis of alcohol use disorder, defined as meeting DSM-5 criteria or documented in the patient's medical record within the past 12 months.\n5. Patients taking opioid medications with a daily Oral Morphine Equivalent (OME) of ≥ 80 mg\n6. Current use of medications or substances known to alter cortical excitability or possess psychoactive properties (e.g., antiepileptics, benzodiazepines, antidepressants, antipsychotics, hallucinogens, dissociatives), as determined by review of the patient's medication list, chart review, and patient history. This includes prescribed medications and illicit substances used within the past 30 days.\n7. Have metallic implants or objects in or on the head, including mouth (e.g. electrodes, stents, clips, pins, braces, shrapnel, jewellery (unremovable)\n8. Use passive or active implanted medical devices (e.g., pacemakers, defibrillators, cochlear implants, natural implants or active body-worn medical devices (e.g., neural stimulation or medication infusion devices)\n9. Have defects in the neurocranium (e.g., post-skull trepanation)\n10. Have large vessel occlusions (e.g., complete blockage of the internal carotid artery or other conditions affecting brain perfusion\n11. Have skin diseases of the scalp\n12. Are using other brain stimulation devices concurrently\n13. Are pregnant\n14. Are unable to provide informed consent\n15. Are unable to wear or tolerate the study device\n16. Unable to speak or read English, or understand device operation instructions",{"count":60,"type":22},[25],"Total knee arthroplasty (TKA) is widely performed to reduce pain from advanced osteoarthritis, yet many patients experience severe postoperative pain and up to 25-44% develop chronic postsurgical pain (CPSP). Transcranial direct current stimulation (tDCS), a non-invasive neuromodulation technique, has shown promise in reducing pain and opioid use in early studies but has not been evaluated using comprehensive perioperative, home-based protocols. This study will test whether a home-based tDCS intervention delivered before and after TKA can improve acute pain management and reduce the development of CPSP.",[29,92,93],"Transcranial Direct Current Stimulation","Pain, Postoperative","2026-01-09",{"date":96,"type":43},"2026-01-20",{"date":98,"type":22},"2026-05",{"date":100,"type":22},"2027-12",{"name":102,"class":50},"Women's College Hospital",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100614937","effectiveness-satisfaction-and-usability-of-virtual-reality-in-the-management-of-postoperative-pain-in-patients-undergoing-knee-arthroplasty-100614937","NCT07286084","Effectiveness, Satisfaction, and Usability of Virtual Reality in the Management of Postoperative Pain in Patients Undergoing Knee Arthroplasty","Inclusion Criteria:\n\n* Adults ≥18 years of age, both sexes\n* Scheduled unilateral knee arthroplasty\n* Adequate cognitive and functional capacity to use virtual reality\n* Signed informed consent\n\nExclusion Criteria:\n\n* Neurological or psychiatric disorders (history of epilepsy, seizures, psychosis, schizophrenia, claustrophobia, tremor, rigidity)\n* Significant visual or hearing impairments that hinder VR use\n* Physical or motor limitations preventing the use of VR headsets or maintaining the required posture\n* Score ≥4 on the 4AT delirium screening tool\n* Pregnancy\n* Recreational drug or alcohol use\n* Inability to complete the intervention protocol",{"count":110,"type":22},45,[25],"The goal of this clinical trial is to evaluate the effectiveness of using virtual reality glasses to reduce the need for rescue analgesia in patients with acute postoperative pain after knee arthroplasty.\n\nThe main questions it aims to answer are:\n\n* What is the impact of virtual reality use on postoperative pain perception as measured by the Visual Analogue Scale (VAS)?\n* What potential adverse effects are associated with the use of virtual reality in the postoperative context?\n* What is the level of satisfaction and acceptance of virtual reality as a complementary strategy for pain management?\n* How does virtual reality influence quality of life and psychosocial variables in patients with acute postoperative pain after knee arthroplasty?",[29],[69,115,116,65],"postoperative pain","acute pain","2025-12-03",{"date":119,"type":43},"2025-12-16",{"date":121,"type":22},"2025-12-27",{"date":123,"type":22},"2026-12-30",{"name":125,"class":50},"Universidad Francisco de Vitoria",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":23,"phases":135,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":147,"leadSponsor":148,"locationsCount":51},"100608430","the-effect-of-rehabilitative-nursing-care-practices-on-frail-patients-undergoing-knee-arthroplasty-and-their-caregivers-100608430","NCT07201454","The Effect of Rehabilitative Nursing Care Practices on Frail Patients Undergoing Knee Arthroplasty and Their Caregivers","Holistic Evaluation of the Effects of Rehabilitative Nursing Care Practices on Frail Patients Undergoing Knee Arthroplasty and Their Caregivers","Inclusion Criteria:\n\n* Literate\n* Speak and understand Turkish\n* Be over 18 years of age\n* Have a patient they care for undergoing knee arthroplasty\n* Be a caregiver for a frail patient who scores 7 or higher on the Edmonton Frailty Scale\n* Provide primary care for the patient\n* Voluntarily participate in the study\n\nExclusion Criteria:\n\nPatient-related exclusion criteria:\n\n* Developing serious surgical complications (e.g., infection, embolism, prosthesis rejection, etc.) after knee arthroplasty\n* Admission to the intensive care unit after surgery\n* Re-surgery during the postoperative period\n* Death of the patient during the study\n* Voluntary withdrawal from the study or lack of communication\n\nCaregiver-related exclusion criteria:\n\n* Transfer of caregiving role to another person after the study begins\n* Caregivers experiencing a physical or psychological health problem that would prevent them from continuing the study\n* Caregivers refusing to continue the study or lack of communication",{"count":134,"type":22},50,[25],"This study was designed to holistically examine the effects of curative nursing care practices based on human caring theory on frail patients and their caregivers undergoing knee arthroplasty.",[29],[69,139,140,141,142,143],"fragile patient","care burden","feeling stuck","caregiver","human care theory","2025-09-23",{"date":45,"type":43},{"date":45,"type":22},{"date":123,"type":22},{"name":149,"class":50},"Ataturk University",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":23,"phases":159,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":51},"100572132","effect-of-music-listened-during-knee-arthroplasty-with-spinal-anesthesia-on-anxiety-pain-and-cortisol-levels-100572132","NCT06729294","Effect of Music Listened During Knee Arthroplasty With Spinal Anesthesia on Anxiety, Pain and Cortisol Levels","Effect of Binaural Beat Music Played During Knee Arthroplasty With Spinal Anesthesia on Anxiety, Pain and Cortisol Levels.","Inclusion Criteria:\n\n* Patients who are older than 18 years,\n* Who have undergone unilateral knee arthroplasty under spinal anesthesia for the first time,\n* Who can communicate verbally,\n* Who are in the ASA 1-2-3 group,\n* Who do not have a neurological or psychiatric diagnosis will be included in the study.\n* Since cortisol levels will be measured in our study, the first cases of the day will be included in the study.\n\nExclusion Criteria:\n\n* Patients who refused to participate in the study were those with hearing impairment due to age or disease,\n* Those who had any contraindications for spinal anesthesia,\n* Those who were transferred to intensive care after the procedure,\n* Those who developed complications during and after the procedure,\n* Those who underwent general anesthesia,\n* Those whose type of anesthesia was changed during surgery.",{"count":158,"type":22},40,[25],"The aim of this study is to examine the effects of binaural beat music played during spinal anesthesia knee arthroplasty on anxiety, pain and cortisol levels. The study was planned as a randomized controlled experimental design study. The hypotheses of the study are as follows;\n\n* Binaural beat music played during spinal anesthesia knee arthroplasty has no effect on anxiety.\n* Binaural beat music played during spinal anesthesia knee arthroplasty has an effect on anxiety.\n* Binaural beat music played during spinal anesthesia knee arthroplasty has no effect on pain levels.\n* Binaural beat music played during spinal anesthesia knee arthroplasty has an effect on pain levels.\n* Binaural beat music played during spinal anesthesia knee arthroplasty has no effect on cortisol levels.\n* Binaural beat music played during spinal anesthesia knee arthroplasty has an effect on cortisol levels.\n\nA sample group will be formed with 20 patients in the intervention group and 20 patients in the control group. Binaural beat music will be played in the intervention group during the surgical procedure, and routine interventions will be applied to the control group.\n\nData collection in the intervention group is as follows;\n\n* Patients will be interviewed in the surgery clinic before surgery and the descriptive characteristics form and the State Anxiety Inventory Form will be filled out.\n* The 1st measurement of hemodynamic data will be recorded immediately before the surgery\n* A musical concert will be started as soon as the surgery begins\n* The musical concert will end when the surgery ends\n* The 2nd measurement will be recorded immediately after the surgery ends\n* In the post-surgery collection unit, the State Anxiety Inventory Form and the Visual Comparison Scale will be used, and a blood sample will be taken to determine cortisol values.\n\nThe control group data collection methods are as follows;\n\n* Patients will be interviewed in the surgical clinic before surgery and the descriptive characteristics form and the State Anxiety Inventory Form will be filled in\n* The first measurement of hemodynamic data will be recorded immediately before the surgical procedure\n* The second measurement will be recorded immediately after the surgical procedure is completed\n* Blood samples will be taken in the post-surgical recovery unit to determine the State Anxiety Inventory Form, Visual Comparison Scale and cortisol values.",[162,29],"Spinal Anesthesia",[164,165,66,166],"binaural beat music","anxiety","cortisol","2025-08-14",{"date":169,"type":43},"2025-08-20",{"date":171,"type":43},"2025-02-01",{"date":173,"type":22},"2026-02",{"name":175,"class":50},"Nuh Naci Yazgan University",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":184,"targetDuration":186,"studyType":187,"phases":4,"briefSummary":188,"conditions":189,"keywords":192,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":4},"100598097","risk-of-serious-adverse-events-following-unsupervised-vs-supervised-rehabilitation-after-knee-arthroplasty-100598097","NCT07067060","Risk of Serious Adverse Events Following Unsupervised vs Supervised Rehabilitation After Knee Arthroplasty","Risk of Serious Adverse Events Following Unsupervised vs Supervised Rehabilitation After Knee Arthroplasty: Protocol For An Emulated Noninferiority Trial (SAFE-T)","SAFE-T","Inclusion Criteria:\n\n* Adults undergoing primary total or unicompartmental knee arthroplasty (KA) for osteoarthritis in Denmark\n\nExclusion Criteria:\n\n* None",{"count":185,"type":22},40000,"2 Years","OBSERVATIONAL","SUMMARY\n\nBackground:\n\nAfter knee arthroplasty (KA), rehabilitation is widely recommended, yet its clinical effectiveness-especially the need for supervision-has been challenged. While some argue that supervised rehabilitation may prevent serious adverse events (SAEs), previous trials show no superiority of rehabilitation, supervised or not, over no rehabilitation in terms of function. However, these trials were underpowered for safety outcomes. A large-scale evaluation is needed to determine if supervision impacts SAE risk, thereby informing rational use of health care resources.\n\nRationale for the proposed study. A conventional randomized trial to assess the safety of supervised versus unsupervised rehabilitation after KA would require an ethically and logistically infeasible sample size. By emulating such a trial using routinely collected registry data, the investigators can estimate the causal effect of supervision on the risk of serious adverse events-while accounting for confounding and preserving real-world relevance.\n\nActionable objective and hypothesis: To test whether unsupervised rehabilitation after knee arthroplasty increases the risk of serious adverse events over a 2-year period compared with supervised rehabilitation. The investigators hypothesize that unsupervised rehabilitation is non-inferior, defined as a hazard ratio for SAE risk below 1.4.\n\nDesign: Target trial emulation (TTE) using nationwide registry data to replicate the design and intent of a pragmatic randomized trial.\n\nSetting: Danish hospitals and municipalities. Patients: Adults undergoing primary total or unicompartmental knee arthroplasty for osteoarthritis, identified from Danish registries. The target trial assumes consecutive recruitment at hospital discharge to mirror real-world referral practices.\n\nInterventions: Referral to unsupervised home-based exercise or supervised municipal physiotherapy, defined by referral to rehabilitation pathways initiated at hospital discharge.\n\nMethods: Primary outcome is serious adverse events; secondary is number of hospital contacts. Propensity score-based weighting will adjust for confounding using patient and administrative covariates (e.g. age, BMI, comorbidities, surgery year), enabling causal inference from observational data.\n\nResults: Findings will inform clinical practice by estimating the comparative safety of unsupervised versus supervised rehabilitation after knee arthroplasty, based on real-world data from over 40,000 patients.\n\nLimitations: As with all non-randomized studies, residual confounding is possible. Despite adjustment strategies, causal interpretations should be made with caution due to reliance on observational data.\n\nConclusion: While TTE can provide valuable insight, the causal inferences made with TTE should be interpreted with caution, when not supported with an RCT.\n\nFunding: Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital is supported by a core grant from the Oak Foundation (OFIL-24-074).\n\nExternal funding: in process. Registration: TBD (registration on ClinicalTrials.Gov)",[190,29,191],"Total Knee Arthroplasty","Unicompartmental Knee Arthroplasty",[193,194,35,195,196,197],"emulated target trial","total knee replacement","serious adverse events","supervised rehabilitation","unsupervised rehabilitation","2025-07-29",{"date":200,"type":43},"2025-07-31",{"date":202,"type":22},"2026-01-01",{"date":204,"type":22},"2027-12-31",{"name":206,"class":50},"Copenhagen University Hospital, Hvidovre",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":23,"phases":216,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":230},"100495849","phase-2-yale-steroid-enhanced-versus-exparel-nerveblock-tka-part-2-100495849","NCT05736549","Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2","Yale SEVEN","Inclusion Criteria:\n\n* American Society of Anesthesiologists status I, II and III, elective, primary, bilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.\n\nExclusion Criteria:\n\n* Refusal of consent\n* Pregnancy\n* Conditions making the patient unable to fill out questionnaire online, through email or over the phone including with cognitive dysfunction, psychiatric disorder, or non-English speaking patients, or lack of internet access which would prevent post discharge follow-up electronically\n* Coagulopathy\n* Allergy to or for any other reasons cannot use Acetaminophen, Celebrex, local anesthetic bupivacaine, DEX, MPA or LB\n* Patients on any amounts of opioids within one month of the surgery date, any substance abuse such as regular marijuana user (more frequent than once per month)\n* Insulin dependent or uncontrolled diabetes defined as, day of surgery finger stick glucose \\>200mg\u002Fdl, or HbA1C \\> 8.0%\n* Peripheral Nerve Block site or systemic infection\n* Immune compromise (e.g., HIV, chronic glucocorticoid use)\n* Severe pre-existing neuropathy\n* TKA for indications other than osteoarthritis such as post-traumatic injury or rheumatoid arthritis, history of surgery in the ipsilateral knee joint, revision TKA or bilateral TKA\n* Severe hepatic or renal dysfunction (GFR \\\u003C50 ml\u002Fmin)\n* Actual body weight \\\u003C60 kg\n* Patients with active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and non-specific ulcerative colitis",{"count":215,"type":22},66,[217],"PHASE2","The objective of this study is to investigate the efficacy of Dexamethasone sodium phosphate plus Methylprednisolone acetate in combination with plain bupivacaine ((B-DEX-MPA) compared with Liposomal Bupivacaine in combination with plain bupivacaine (B-LB) on post-surgical pain control among patients undergoing bilateral total knee arthroplasty (TKA) to asses if perineural B-DEX-MPA will result in superior analgesia efficacy as compared to B-LB.\n\nThis study will also assess if perineural B-DEX-MPA results in improved quality of postoperative recovery as compared to B-LB.",[220,29],"Total Knee Replacement","2025-05-13",{"date":223,"type":43},"2025-05-14",{"date":225,"type":43},"2023-02-07",{"date":227,"type":22},"2028-03",{"name":229,"class":50},"Yale University",2,{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":212,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":23,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":247,"locationsCount":230},"100460704","phase-2-yale-steroid-enhanced-versus-exparel-nerveblock-tka-rct-study-100460704","NCT05279092","Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study","Yale Steroid Enhanced Versus Exparel Nerveblock TKA Randomized Controlled Trial (RCT) Study","Inclusion Criteria:\n\n* American Society of Anesthesiologists status I, II and III, elective, primary, unilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.\n\nExclusion Criteria:\n\n* Refusal of consent\n* Pregnancy\n* Conditions making the patient unable to fill out questionnaire online, through email or over the phone including with cognitive dysfunction, psychiatric disorder, or non-English speaking patients, or lack of internet access which would prevent post discharge follow-up electronically\n* Coagulopathy\n* Allergy to or for any other reasons cannot use Acetaminophen, Celebrex, local anesthetic bupivacaine, DEX, MPA or LB\n* Patients on any amounts of opioids within one month of the surgery date, any substance abuse such as regular marijuana user (more frequent than once per month)\n* Insulin dependent or uncontrolled diabetes defined as, day of surgery finger stick glucose \\>200mg\u002Fdl, or HbA1C \\> 8.0%\n* Peripheral Nerve Block site or systemic infection\n* Immune compromise (e.g., HIV, chronic glucocorticoid use)\n* Severe pre-existing neuropathy\n* TKA for indications other than osteoarthritis such as post-traumatic injury or rheumatoid arthritis, history of surgery in the ipsilateral knee joint, revision TKA or bilateral TKA\n* Severe hepatic or renal dysfunction (GFR \\\u003C50 ml\u002Fmin)\n* Actual body weight \\\u003C60 kg\n* Patients with active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and non-specific ulcerative colitis",{"count":239,"type":22},250,[217],"The objective of this phase 2 study is to investigate the efficacy of Dexamethasone sodium phosphate (DEX) plus Methylprednisolone acetate (MPA) in combination with plain bupivacaine (B) compared with Liposomal Bupivacaine (LB) in combination with plain bupivacaine on post-surgical pain control among patients undergoing unilateral total knee arthroplasty (TKA) to asses if perineural B-DEX-MPA will result in superior analgesia efficacy as compared to B-LB.\n\nThis study will also assess if perineural B-DEX-MPA results in improved quality of postoperative recovery as compared to B-LB.",[220,29],{"date":223,"type":43},{"date":245,"type":43},"2022-09-08",{"date":227,"type":22},{"name":229,"class":50},{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":18,"minAge":256,"maxAge":257,"enrollmentInfo":258,"targetDuration":4,"studyType":187,"phases":4,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":4},"100564825","the-dubousset-functional-test-in-total-knee-arthloplasty-100564825","NCT06634212","The Dubousset Functional Test in Total Knee Arthloplasty","Validity and Reliability of Dubousset Functional Test in Total Knee Arthloplasty","DFT-TKA","Inclusion Criteria:\n\n* Patients who had Total Knee Arthroplasty\n* Patients aged 50-70 years.\n\nExclusion Criteria:\n\n* Patients who didn't have any Total Kne arthroplasty\n* hose with fractures, pregnancy, a disease that would prevent physical exertion, those with a body mass index (BMI) of 40 kg\u002Fm2 and above, and those with major musculoskeletal or neurological disorders that cause gait disturbance will be excluded from the study.","50 Years","70 Years",{"count":259,"type":22},60,"The aim of this study is to investigate the validity and reliability of Dubousset Functional Test in the patients with Total Knee Prothesis.",[29],"2024-10-08",{"date":264,"type":43},"2024-10-09",{"date":266,"type":22},"2024-11-15",{"date":268,"type":22},"2025-07-15",{"name":270,"class":50},"Alanya Alaaddin Keykubat University"]